Drug & Medication Defects Recalls

Azelaic Acid Gel

CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%)

Lack of Assurance of Sterility

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%)

Lack of Assurance of Sterility

Rising

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

Levothyroxine Sodium Tablets

Subpotent Drug

BD ChloraPrep Clear

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL)

Lack of Assurance of Sterility

Dextroamphetamine Saccharate

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

TopCare Health

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

LEADER

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

GOOD NEIGHBOR PHARMACY

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Foster & Thrive

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

FAMILY Wellness

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

CVS Health

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

CAREone

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

AUDIOLOGIST'S CHOICE

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

Pemetrexed for Injection 500mg/Vial

Lack of Sterility Assurance

Pemetrexed for Injection 100mg/Vial

Lack of Sterility Assurance

Bortezomib for Injection 3.5mg/Vial

Lack of Sterility Assurance

Azacitidine for Injection 100mg/Vial

Lack of Sterility Assurance

Nystatin Cream USP

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

Glucagon Emergency Kit for Low Blood Sugar

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Perampanel CIII Tablets

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Carton Label: MAJOR

Subpotent Drug

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

ChloraPrep FREPP

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD PurPrep

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep Scrub Teal

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep Scrub Teal

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep Hi-Lite Orange

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep Hi-Lite Orange

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep Hi-Lite Orange

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep CLear

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep CLear

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

BD ChloraPrep Clear

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

IMULDOSA

Lack of assurance of Sterility:

Lidocaine HCl Injection USP

Lack of Assurance of Sterility

Accucaine

Lack of Assurance of Sterility

Levothyroxine Sodium Tablets

Subpotent Drug

Povi-One

sub potency

Sensipar (cinacalcet) Tablets

CGMP Deviations

Sensipar (cinacalcet) Tablets

CGMP Deviations

Sensipar (cinacalcet) Tablets

CGMP Deviations

Rapidol

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Med Pride

CGMP Deviations; deficiencies observed during FDA inspection

Lucky Super Soft

CGMP Deviations; deficiencies observed during FDA inspection

Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt

CGMP Deviations; deficiencies observed during FDA inspection

Lil Drug Store

CGMP Deviations; deficiencies observed during FDA inspection

Cura Hongos

CGMP Deviations; deficiencies observed during FDA inspection

Circle K

CGMP Deviations; deficiencies observed during FDA inspection

Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6

Subpotent drug

Gasco Isopropyl Alcohol 70%

Subpotent drug

Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz

Subpotent drug

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%

Subpotent drug

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%

Subpotent drug

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%

Subpotent drug

BD ChloraPrep FREPP Clear

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

BD ChloraPrep Clear

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Fenofibrate Capsules

CGMP Deviations

Xyvona (levorphanol tartrate tablets)

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Xyvona (levorphanol tartrate tablets)

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz

Defective container:may contain bottles with incomplete seals

Quala Dental Products

Defective container:may contain bottles with incomplete seals

PureLife

Defective container:may contain bottles with incomplete seals

Pearson Quality Topical Anesthetic Gel (20% Benzocaine)

Defective container:may contain bottles with incomplete seals

DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz

Defective container:may contain bottles with incomplete seals

Dental City TOPICAL ANESTHETIC GEL

Defective container:may contain bottles with incomplete seals

Burkhart topical anesthetic gel

Defective container:may contain bottles with incomplete seals

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9)

cGMP deviations

PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

Lack of Assurance of Sterility

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC

Subpotent Drug

Great Value Hawaiian Roll 4pk, Item # F63384

Firm observed oily and sticky substance on direct food contact surface packaging of finished product.

Lidocaine HCl Injection USP

Lack of Assurance of Sterility

fentaNYL Citrate

Subpotent Drug

Estradiol Gel

Defective Container; packets were found to be either empty or partially full.

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

cimzia (certolizumab pegol)

Lack of Assurance of Sterility

My Wife's Slaw Jalapeno Heat, packaged in 8 oz

Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.

My Wife's Slaw, packaged in 8 oz

Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.

Atomoxetine Capsules HCL

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Travel Size Afrin® Original Nasal Spray 6 mL Bottles

The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as required by the Poison Prevention Packaging Act. The 6 mL nasal spray's packaging is not child-resistant nor bears the required labeling statement, posing a risk of serious injury or illness from poisoning, if the contents are swallowed by young children.

Oasis Tears PF

Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

Octreotide Acetate for Injectable Suspension

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Similasan

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

iVIZIA

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Systane

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

GenTeal Tears

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Optase Dry Eye Intense Drops (Glycerin 0.2%)

Lack of Assurance of Sterility

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA

Lack of Assurance of Sterility

Omega-3-Acid

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

vite20 Antifungal Cream

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TERPENICOL Antifungal Solution

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TERPENICOL Antifungal Cream (Undecylenic Acid 13%)

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Desmopressin Nasal Spray

Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

DELFLEX

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

DELFLEX

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Lidocaine HCl Injection

Lack of Assurance of Sterility

Lidocaine HCl injection

Lack of Assurance of Sterility

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

cGMP deviations.

Ketamine Hydrochloride Injectable Solution

cGMP deviations.

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15

cGMP deviations.

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride

cGMP deviations.

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride

cGMP deviations.

fentaNYL Citrate Injectable Solution

cGMP deviations.

fentaNYL Citrate Injectable Solution

cGMP deviations.

Label is predominantly green with white lettering in a clear plastic clamshell container

mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So

Lack of Assurance of Sterility

Blemish Spot Treatment (Salicylic Acid) 1%

Failed Stability Specifications

Fluocinonide

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Fluocinonide

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Fluocinonide

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%)

Lack of Assurance of Sterility

Discount Drug Mart Food Market

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Discount Drug Mart Food Market

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Clonidine Transdermal System

CGMP Deviations: use of an unapproved raw material

Clonidine Transdermal System

CGMP Deviations: use of an unapproved raw material

Clonidine Transdermal System

CGMP Deviations: use of an unapproved raw material

Octreotide Acetate for Injectable Suspension

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Octreotide Acetate for Injectable Suspension

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Octreotide Acetate for Injectable Suspension

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

CUROSURF (poractant alfa)

Lack of Assurance of Sterility

Meclizine Hydrochloride Tablets

Failed tablet specifications.

Lanreotide Injection

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Lanreotide Injection

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

5% Dextrose Injection

Lack of Assurance of Sterility

5% Dextrose Injection

Lack of Assurance of Sterility

5% Dextrose Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility

0.45% Sodium Chloride Injection

Lack of Assurance of Sterility

Semaglutide-Glycine-Cyanocobalamin Injectable

Lack of Assurance of Sterility

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp

Lack of Assurance of Sterility

Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%)

Lack of Assurance of Sterility

STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%)

Lack of Assurance of Sterility

Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%)

Lack of Assurance of Sterility

Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)

Lack of Assurance of Sterility

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl

Lack of Assurance of Sterility

EYE DROPS Advanced Relief

Lack of Assurance of Sterility

Dry Eye Relief Eye Drops

Lack of Assurance of Sterility

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%)

Lack of Assurance of Sterility

Tirzepatide Inj

Lack of Assurance of Sterility

Tirzepatide Inj

Lack of Assurance of Sterility

Semaglutide Inj

Lack of Assurance of Sterility

Semaglutide Inj

Lack of Assurance of Sterility

Levothyroxine Sodium Tablets USP 150 mcg

Subpotent Drug

MAXIMUM

Stability Data Does Not Support Expiry Date.

MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014

Stability Data Does Not Support Expiry Date.

FIVE-STAR

Stability Data Does Not Support Expiry Date.

Midodrine Hydrochloride Tablets

Defective container; inadequately sealed blister packaging.

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd

Defective Delivery System: Missing or duplicated needles within the injection kit

vancomycin HCl

Lack of Assurance of Sterility

vancomycin HCl

Lack of Assurance of Sterility

thiamine HCl

Lack of Assurance of Sterility

ketamine HCl

Lack of Assurance of Sterility

acyclovir sodium

Lack of Assurance of Sterility

Pro Numb Tattoo Numbing Spray

cGMP deviations

Pro Numb Tattoo Numbing Spray

cGMP deviations

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S

CGMP Deviations

Wipes Plus

CGMP Deviations

Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02

CGMP Deviations

Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%)

CGMP Deviations

Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%)

CGMP Deviations

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)

CGMP Deviations

Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%)

CGMP Deviations

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%)

CGMP Deviations

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St

CGMP Deviations

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03

CGMP Deviations

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04

CGMP Deviations

First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%)

CGMP Deviations

Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%)

CGMP Deviations

Dynarex

CGMP Deviations

Dynarex

CGMP Deviations

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case

CGMP Deviations

Cleansing Towelette (Benzalkonium Chloride 0.13%)

CGMP Deviations

Children's Healthcare of Atlanta

CGMP Deviations

BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)

CGMP Deviations

Antimicrobial Alcohol Hand Wipe

CGMP Deviations

1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes

CGMP Deviations

Thyroid

Subpotent Drug

methylprednisolone tablets

Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.

spicely ORGANIC sumac NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT

Product contains salt and is mislabeled

spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR

Product contains salt and is mislabeled

spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR

Product contains salt and is mislabeled

Oxycodone Hydrochloride Tablets

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

cGMP deviations.

Vista Tears Polyethylene Glycol 400 0.4% w/v

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

CHNaO Fluorescein Sodium Ophthalmic Strips

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Bio Glo Fluorescein Sodium Ophthalmic Strips USP

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

Ondansetron Orally Disintegrating Tablets

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone)

Failed Disintegration Specifications: above the time expected.

Oxycodone and Acetaminophen CII Tablets USP

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Oxycodone and Acetaminophen CII Tablets USP

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

cGMP Deviations

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz

cGMP Deviations

Ondansetron ODT Tablets

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Sertraline Hydrochloride Tablets USP

Defective container - seal not adhering to bottles

OraVerse

Defective container: cracked/broken cartridges

Lidocaine HCI 2% and Epinephrine 1:100

Defective container: cracked/broken cartridges

darby dental supply

Defective container: cracked/broken cartridges

Cook-Walte

Defective container: cracked/broken cartridges

Benco dental Graham CHEMICAL CO

Defective container: cracked/broken cartridges

3% Polocaine DENTAL

Defective container: cracked/broken cartridges

2% Xylocaine DENTAL with Epinephrine 1:100

Defective container: cracked/broken cartridges

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd

Failed Stability Specifications: Observed OOS results: eg results for colour index

WeCare, Zinc Oxide Ointment, Net Wt

cGMP deviations

Wecare Enema

cGMP deviations

Wecare Calasoothe, Net wt

cGMP deviations

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt

cGMP deviations

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt

cGMP deviations

Nivagen, Zinc Oxide Ointment, Net Wt

cGMP deviations

Lanashield Skin Barrier, 4 oz

cGMP deviations

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt

cGMP deviations

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz

cGMP deviations

Globe Clotrimazole Cream, USP, 1 %, Net Wt

cGMP deviations

Dynashield Skin Protectant, Net Wt

cGMP deviations

Dynashield

cGMP deviations

Dynagel, Moisturizing Wound Hydrogel, Net Wt

cGMP deviations

Lanthanum Carbonate chewable tablets

Failed stability specifications: Out of specification for hardness test

Lanthanum Carbonate chewable tablets

Failed stability specifications: Out of specification for hardness test

Acetaminophen 500mg Caffeine 65mg caplets

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Tirzepatide Injection

Lack of Assurance of Sterility

Semaglutide Injection

Lack of Assurance of Sterility

Semaglutide Injection

Lack of Assurance of Sterility

Semaglutide Injection

Lack of Assurance of Sterility

Semaglutide Injection

Lack of Assurance of Sterility

Amoxicillin and Clavulanate Potassium for Oral Suspension USP

Subpotent drug; Clavulanate Potassium component

HADLIMA (adalimumab-bwwd) injection

Lack of Assurance of Sterility.

Haloperidol Lactate Injection

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist

CGMP Deviations

Sea Enzyme Ultra Umbrella Sunscreen SPF 30

CGMP Deviations

Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT

CGMP Deviations

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist

CGMP Deviations

Elixir by Coco March Tinted Mineral Sunscreen SPF 50

CGMP Deviations

Elixir by Coco March Mineral Sunscreen SPF 50

CGMP Deviations

Dr

CGMP Deviations

Doctor

CGMP Deviations

Doctor D

CGMP Deviations

Doctor D

CGMP Deviations

Doctor D

CGMP Deviations

Doctor D

CGMP Deviations

Doctor D

CGMP Deviations

CLEARSTEM YOU ARE SUNSHINE SPF 50

CGMP Deviations

Fentanyl citrate

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Phenylephrine HCI

CGMP Deviations